Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05983835
Status:
UNKNOWN
Last Update Posted:
2023-08-09
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 688}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival', 'timeFrame': '2 years', 'description': "This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IA Lung Adenocarcinoma', 'Combined Segmentectomy']}, 'descriptionModule': {'briefSummary': 'This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) , Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) PS score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy.\n\n (7) FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant metastasis were found in the preoperative clinical evaluation, (9) voluntary participation and informed consent were obtained;\n\nExclusion Criteria:\n\n* (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple GGO considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.'}, 'identificationModule': {'nctId': 'NCT05983835', 'briefTitle': 'Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'Union-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combined segmentectomy', 'interventionNames': ['Procedure: Patients receive subsegmentectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'lobectomy', 'interventionNames': ['Procedure: Patients receive subsegmentectomy']}], 'interventions': [{'name': 'Patients receive subsegmentectomy', 'type': 'PROCEDURE', 'description': 'Patients receive lobectomy', 'armGroupLabels': ['combined segmentectomy', 'lobectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wu Jieping Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}